PRECISION BIOSCIENCES INC
For the period ended Mar 31, 2025. Filed May 15, 2025.
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Mar 31, 2025 · Filed May 15, 2025
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Notes to Condensed Financial Statements
Notes to Condensed Financial Statements (Unaudited)
NOTE 1: DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business
Precision BioSciences, Inc. (the “Company”) was incorporated on January 26, 2006 under the laws of the State of Delaware and is based in Durham, North Carolina. The Company is a gene editing company dedicated to improving life by developingin vivo therapies for genetic and infectious diseases with the application of the Company’s wholly-owned proprietary ARCUS genome editing platform.
Since its inception, the Company has devoted substantially all of its efforts to research and development activities, recruiting skilled personnel, establishing its intellectual property portfolio and providing general and administrative support for these operations. The Company is subject to a number of risks similar to those of other companies conducting early-stage research and development of product candidates. Principal among these risks are the Company’s dependence on key individuals and intellectual property, competition from other products and companies, and the technical risks associated with the successful research, development and clinical manufacturing of its product candidates. The Company’s success is dependent upon its ability to continue to raise additional capital in order to fund ongoing research and development, obtain regulatory approval of its products, successfully commercialize its products, generate revenue, meet its obligations, and, ultimately, attain profitable operations.
Unaudited Interim Financial Information
The accompanying unaudited condensed financial statements and notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in the annual financial statements, prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”), have been condensed or omitted pursuant to those rules and regulations. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 26, 2025.
The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair presentation of the Company’s condensed financial position as of March 31, 2025 and condensed results of operations for the three months ended March 31, 2025 and 2024 and the condensed cash flows for the three months ended March 31, 2025 and 2024, have been made. The Company’s condensed results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025.
Discontinued Operations
In August 2023, the Company announced its strategic decision to operate as a single platform company focused exclusively on developingin vivo gene editing therapies with the completion of the sale of its chimeric antigen receptor (“CAR”) T infrastructure to Imugene Limited, an Australian corporation (“Imugene Limited”), and its wholly-owned subsidiary Imugene (USA) Inc. (“Imugene US”), a Nevada corporation (collectively, “Imugene”). Additionally, the Company licensed its lead allogeneic CAR T candidate for cancer, azercabtagene zapreleucel (“azer-cel”), to Imugene.
Accordingly, the accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities and expenses related to the Company’s CAR T programs as discontinued operations (see Note 8, Discontinued Operations). The accompanying condensed financial statements are generally presented in conformity with the Company’s historical format.
Summary of Significant Accounting Policies
The Company’s complete listing of significant accounting policies is set forth in Note 1, Description of Business and Summary of Significant Accounting Policies, to the Notes to Condensed Financial Statements on its Annual Report on
Form 10-K for the fiscal year ended December 31, 2024. There have been no changes to these policies as of March 31, 2025.
Accounting Standards Updates
Recently Issued Accounting Standards
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to expand the disclosure requirements for income taxes. Upon adoption, companies will be required to disclose additional specified categories in the rate reconciliation. Companies will also be required to disclose the amount of income taxes paid disaggregated by jurisdiction, among other disclosure requirements. The standard is effective for annual periods beginning after December 15, 2024, and can be applied either prospectively or retrospectively. We plan to adopt the standard in our 2025 annual period and are currently assessing its effect on our financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to improve disclosures around an entity’s expenses. Upon adoption, companies will be required to disclose in the notes to the financial statements a disaggregation of certain expense categories included within the expense captions on the face of the income statement. The standard is effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027, with early adoption permitted, and can be applied either prospectively or retrospectively. We plan to adopt the standard in our 2027 annual period and are currently assessing its effect on our financial statement disclosures.
NOTE 2: FAIR VALUE MEASUREMENTS
The following represents assets and liabilities measured at fair value on a recurring basis by the Company (in thousands):
| March 31, 2025 | Fair Value | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Assets: | ||||
| Money market funds | $14,843 | $14,843 | $— | $— |
| Investment in iECURE | 3,206 | — | — | 3,206 |
| Assets held for sale | 169 | — | — | 169 |
| $18,218 | $14,843 | $— | $3,375 | |
| Liabilities: | ||||
| Final payment fee | $197 | $— | $197 | $— |
| Warrant liability | 3,600 | — | — | 3,600 |
| $3,797 | $— | $197 | $3,600 | |
| December 31, 2024 · Fair Value · Level 1 · Level 2 · Level 3 | |||||
|---|---|---|---|---|---|
| Assets: | |||||
| Money market funds | $14,687 | $14,687 | $— | $— | |
| Investment in iECURE | 3,206 | — | — | 3,206 | |
| Imugene Marketable Securities | 413 | 413 | — | — | |
| Assets held for sale | 169 | — | — | 169 | |
| $18,475 | $15,100 | $ | - | $3,375 | |
| Liabilities: | |||||
| Final payment fee | $194 | $— | $194 | $— | |
| Warrant Liability | 2,796 | — | — | 2,796 | |
| $2,990 | $— | $194 | $2,796 | ||
The following represents a reconciliation of assets measured and carried at fair value on a recurring basis with the use of significant unobservable inputs (Level 3) for thethree months ended March 31, 2025 (in thousands). The warrant reconciliation is disclosed in Note 13, Warrants:
| Investment in iECURE | Assets held for sale | |
|---|---|---|
| Balance December 31, 2024 | $3,206 | $169 |
| Gains from changes in fair value included in earnings | — | — |
| Assets sold | — | — |
| Write-offs | — | — |
| Balance March 31, 2025 | $3,206 | $169 |
The carrying amounts of the Company’s accounts receivable, accounts payable, and accrued expenses and other current liabilities, approximate their respective fair values due to their short-term nature. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis and to minimize the use of unobservable inputs when determining their fair value. The three tiers are defined as follows:
Level 1—Observable inputs based on unadjusted quoted prices in active markets for identical assets or liabilities
Level 2—Inputs, other than quoted prices in active markets, which are observable either directly or indirectly
Level 3—Unobservable inputs for which there is little or no market data, which require the Company to develop its own assumptions
NOTE 3: DEBT
Loan and Security Agreement
On July 31, 2024, the Company entered into an amended and restated loan and security agreement (the “2024 Loan and Security Agreement”) with Banc of California pursuant to which Banc of California provided the Company with a term loan with a principal amount of $22.5 million (the “2024 Term Loan”). The 2024 Term Loan bears interest at an annual rate equal to the greater of (i)1.50% below the Prime Rate (as defined in the 2024 Loan and Security Agreement) then in effect or (ii)4.50%. As of March 31, 2025, the stated interest rate on the 2024 Term Loan was 6.00% and the effective interest rate was 6.43%.
Additionally, as of March 31, 2025, $22.5 million in borrowings were outstanding under the 2024 Term Loan and the unamortized debt discount balance was $0.2 million. Refer to Note 12, Debt, to the Company’s audited financial statements included in the Company’s Annual Report for the fiscal year ended December 31, 2024, for more information related to the 2024 Loan and Security Agreement.
NOTE 4: COMMITMENTS AND CONTINGENCIES
Litigation
The Company is subject to various legal matters and claims in the ordinary course of business. Although the results of legal proceedings and claims cannot be predicted with certainty, in the opinion of management, there are currently no such known matters that will have a material effect on the financial condition, results of operations or cash flows of the Company.
Servier Program Purchase Agreement
On April 9, 2021, the Company entered into a program purchase agreement (the “Program Purchase Agreement”) with Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, “Servier”), pursuant to which the Company reacquired all of its global development and commercialization rights previously granted to Servier pursuant to the Development and Commercial License Agreement by and between Servier and the Company, dated February 24, 2016, as amended (the “Servier Agreement”), and mutually terminated the Servier Agreement.
The Program Purchase Agreement requires the Company to make certain payments to Servier based on the achievement of regulatory and commercial milestones for each product. Management assessed the likelihood of each of the regulatory and commercial milestones included in the Program Purchase Agreement in accordance with ASC 450, Contingencies. If the assessment of a contingency indicates that it is probable that the milestone will be achieved and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s condensed financial statements.
Accordingly, contingent liabilities of $10.0 million related to the Program Purchase Agreement are accrued and included in contract liabilities in the condensed balance sheets as of March 31, 2025 and December 31, 2024.
Leases
The Company has an operating lease for real estate in North Carolina and does not have any finance leases.
The elements of lease expense were as follows:
| For the Three Months Ended March 31, | ||
|---|---|---|
| (in thousands) | 2025 | 2024 |
| Lease Cost | ||
| Operating lease cost | $482 | $483 |
| Short-term lease cost | 195 | 189 |
| Variable lease cost | 97 | 81 |
| Sublease income | — | (102) |
| Total Lease Cost | $774 | $651 |
| Other Information | ||
| Operating cash flows used for operating leases | 484 | 462 |
| Operating Leases | ||
| Weighted-average remaining lease term (in years) | 4.3 | 5.3 |
| Operating Leases | ||
| Weighted-average discount rate | 9.2% | 9.2% |
Pursuant to the Imugene Purchase Agreement, Imugene agreed to sublease from the Company space at the Company’s headquarters (the “Imugene Sublease”). In January 2025, Imugene terminated the Imugene Sublease. There is no impact to the condensed balance sheet as a result of the termination as the Company was not relieved of its primary obligation to the lessor under the terms of the Imugene Sublease and continued to carry the related right-of-use assets and lease liabilities on its condensed balance sheets while netting sublease income with lease cost in its condensed statements of operations.
Future minimum lease payments under non-cancelable operating leases with terms of greater than one year as of March 31, 2025, were as follows:
| (in thousands) | Amount |
|---|---|
| 2025 (remainder of year) | $1,477 |
| 2026 | 2,019 |
| 2027 | 2,078 |
| 2028 | 2,140 |
| 2029 | 1,269 |
| Total lease payments | $8,983 |
| Less: imputed interest | 1,572 |
| Total operating lease liabilities | $7,411 |
Guarantees
The Company agreed to act as a guarantor of Imugene’s assumption of the Company’s lease for its Manufacturing Center for Advanced Therapeutics (the “MCAT Lease”) through the lease expiration date of August 31, 2027. If Imugene (including any successor or assignee of Imugene) fails to pay rent due on the MCAT Lease, the lessor may have contractual recourse against the Company.
As of March 31, 2025, the Company’s guarantee consists of a contingent liability for aggregate minimum lease payments of approximately $3.9 million. No contract liability for the Company’s guarantee of Imugene’s performance on the MCAT Lease was recorded as of March 31, 2025, as it was not deemed probable that Imugene will be in default under the MCAT Lease.
Supply Agreements
The Company enters into contracts in the normal course of business with contract manufacturing organizations (“CMOs”) for the manufacture of clinical trial materials and contract research organizations (“CROs”) for clinical trial services. These agreements provide for termination at the request of either party with less than one-year’s notice and are, therefore, cancelable contracts. If canceled, these agreements are not anticipated to have a material effect on the financial condition, results of operations, or cash flows of the Company.
NOTE 5: STOCKHOLDERS’ EQUITY
Capital Structure
On March 1, 2024, the Company entered into an underwriting agreement relating to a public offering of (i)2,500,000 shares of the Company’s common stock, par value $0.000005 per share, and (ii) warrants to purchase up to an aggregate of 2,500,000 shares of the Company’s common stock (the“March 2024 Public Offering”). The warrants have afive-year term and an exercise price of $20.00 per share. Each warrant is exercisable immediately upon issuance, subject to certain limitations on beneficial ownership. The price to the public in the March 2024 Public Offering was $16.00 per share of common stock and accompanying warrants, which resulted in approximately $37.0 million of net proceeds to the Company after deducting the underwriting discount and offering expenses of approximately $3.0 million.
NOTE 6: COLLABORATION AND LICENSE AGREEMENTS
TG Therapeutics
On January 7, 2024, the Company entered into a license agreement (the “TG License Agreement”) with TG Cell Therapy, Inc. (“TG Subsidiary”) and its parent company TG Therapeutics, Inc. (“TG Parent” and, together with TG Subsidiary, “TG Therapeutics”), pursuant to which the Company granted TG Subsidiary certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize azer-cel for autoimmune diseases and other indications outside of cancer pursuant to the terms of the TG License Agreement.
Under the TG License Agreement, the Company was entitled to receive an upfront cash payment of $10.0 million (the “Upfront Payment”), an additional cash payment of $7.5 million in the event that TG Therapeutics achieves a certain clinical milestone that is expected to be achieved in the near-term (the “Initial Milestone Payment”), and additional payments upon the achievement of additional specified milestones of up to $288.6 million (the “Additional Milestone Payments”). As described below, up to $10.0 million of the cash payments potentially payable to the Company are payable in exchange for the issuance (the “Company Stock Issuances”) to TG Subsidiary of shares of the Company’s common stock.
The Upfront Payment of $10.0 million is comprised of (i) a $5.25 million cash payment that was paid to the Company on February 5, 2024, (ii) a $2.25 million cash payment that was paid to the Company on February 5, 2024 in exchange for 97,360 shares of the Company’s common stock, based on a price per share equal to a 100% premium to the VWAP of the Company’s common stock for the 30 trading days prior to the date of the TG License Agreement, and (iii) a deferred cash payment of $2.5 million that was paid to the Company on January 6, 2025 in exchange for 220,712 shares of the Company’s common stock at a price per share of $11.33, which represented a 100% premium to the VWAP of the Company’s common stock for the 30 trading days prior to the date of payment.
During the three months ended March 31, 2025, the Company recognizedno revenue under the TG License Agreement.
Collaboration and License Agreement with Novartis
During the three months ended March 31, 2025, and 2024, the Company recognized revenue under the collaboration and license between the Company and Novartis Pharma AG (the “Novartis Agreement”) of less than $0.1 million and $4.5 million, respectively. Deferred revenue related to the Novartis Agreement amounted to $26.2 million and $26.3 million as of March 31, 2025 and December 31, 2024, respectively, of which $5.7 million and $3.0 million, respectively, was included in current liabilities within the condensed balance sheets.
Development and License Agreement with Prevail
For the three months ended March 31, 2025, the Company recognizedno revenue under the amended and restated development and license agreement between the Company and Prevail Therapeutics Inc. (the“Prevail Agreement”) as it was terminated in the prior year, and the Company subsequently exercised its rights to the return of its three programs. The Company recognized revenue of $4.5 million for thethree months ended March 31, 2024. The Company hasno deferred revenue related to the Prevail Agreement as of March 31, 2025 and December 31, 2024 due to the termination.
Development and License Agreement with iECURE
The Company adjusts the carrying value of the iECURE, Inc. (“iECURE”) equity to fair value each reporting period with any changes in fair value recorded to other income (expense). There wasno change in the fair value of the iECURE equity during thethree months ended March 31, 2025 and the three months ended March 31, 2024.
NOTE 7: SHARE-BASED COMPENSATION
The Company previously granted stock options under its 2015 Stock Incentive Plan (the “2015 Plan”). As of March 31, 2025 there were 29,935 stock options outstanding under the 2015 Plan andno remaining stock options available to be granted under the 2015 Plan.
The 2019 Incentive Award Plan (as amended and restated, the “2019 Plan”)provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units and other share-based awards. The 2019 Plan had 179,468 stock options and 637,457 restricted stock units (“RSUs”) outstanding as of March 31, 2025.
The number of shares available for issuance under the 2019 Plan initially equaled 158,333 shares of common stock. The 2019 Plan provides for an annual increase to the number of shares of common stock available for issuance on the first day of each calendar year beginning January 1, 2020 and ending on and including January 1, 2029 by an amount equal to the lesser of (i)4% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the board of directors. As of March 31, 2025, the aggregate number of shares available for issuance under the 2019 Plan has been increased by 862,285 pursuant to this provision. Additionally, the number of shares available for issuance under the plan was increased by an additional 630,000 shares in connection with the amendment and restatement of the 2019 Plan approved at the Company’s annual meeting of stockholders on June 4, 2024. Any shares that are subject to awards outstanding under the Company’s 2006 Plan and 2015 Plan as of the effective date of the 2019 Plan that expire, lapse, or are terminated, exchanged for cash, surrendered, repurchased, or canceled without having been fully exercised or forfeited, to the extent so unused, will become available for award grants under the 2019 Plan. As of March 31, 2025,440,440 shares were available to be issued under the 2019 Plan.
The purc hase price of the shares under the 2019 ESPP, in the absence of a contrary designation, will be 85% of the lower of the fair market value of our common stock on the first trading day of the offering period or on the purchase date. As of March 31, 2025, we had issued 88,165 shares under the 2019 ESPP. As of March 31, 2025,98,501 shares were available to be issued under the 2019 ESPP. The Company recognized share-based compensation expense related to the 2019 ESPP of less than $0.1 million during thethree months ended March 31, 2025 and March 31, 2024.
The 2021 Employment Inducement Incentive Award Plan (as amended, the “Inducement Award Plan”) provides for the grant of non-qualified stock options, stock appreciation rights, restricted stock, RSUs and other share-based awards to newly hired employees who have not previously been an employee or member of the board, or an employee who is being rehired following a bona fide period of non-employment by the Company. No more than 500,000 shares of the Company’s common stock may be issued under the Inducement Award Plan. As of March 31, 2025,321,111 shares were available to be issued under the Inducement Award Plan. The Inducement Award Plan had 166,193 stock options and 4,806 RSUs outstanding as of March 31, 2025.
The Company recorded employee and nonemployee share-based compensation expense as follows (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Employee | $2,639 | $2,488 |
| Nonemployee | 183 | 418 |
| $2,822 | $2,906 | |
Share-based compensation expense is included in the following line items in the condensed statements of operations (in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development | $503 | $760 |
| General and administrative | 2,319 | 2,146 |
| $2,822 | $2,906 | |
The following table summarizes activity in the Company’s stock option plans for thethree months ended March 31, 2025:
| Outstanding Option Shares | Weighted-Average Exercise Price | |
|---|---|---|
| Balance as of December 31, 2024 | 376,551 | $136.59 |
| Granted | — | — |
| Exercised | — | — |
| Forfeited/canceled | (955) | 281.20 |
| Balance as of March 31, 2025 | 375,596 | $136.22 |
The fair value of each RSU was determined based on the closing market price of the Company’s common stock on the date of grant. The fair value of the RSUs will be recognized as expense over the requisite vesting period.
The following table summarizes the Company’s RSU activity for thethree months ended March 31, 2025:
| RSU Awards | Weighted-Average Grant Date Fair Value | |
|---|---|---|
| Unvested RSUs as of December 31, 2024 | 975,520 | $14.32 |
| Granted | — | — |
| Forfeited | (12,242) | 19.24 |
| Vested | (321,015) | 17.38 |
| Unvested RSUs as of March 31, 2025 | 642,263 | $12.70 |
There was approximately $9.7 million of total unrecognized compensation cost related to unvested stock options and RSUs as of March 31, 2025, which is expected to be recognized over a weighted-average period of 1.4 years.
NOTE 8: DISCONTINUED OPERATIONS
The Company determined that the sale of its cell therapy operations qualified for discontinued operations accounting treatment in accordance with ASC 205-20, Presentation of Financial Statements – Discontinued Operations.
The historical balance sheet and statements of operations of the Company and the related notes to the financial statements have been presented as discontinued operations in the financial statements and prior periods have been recast. Discontinued operations include the results of the Company’s historical cell therapy operations.
The following table shows amounts included in assets and liabilities of discontinued operations, respectively, on the Company’s balance sheets as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Current liabilities of discontinued operations | ||
| Accrued research and development expenses | 885 | 1,204 |
| Total current liabilities of discontinued operations | 885 | 1,204 |
NOTE 9: ELO TRANSACTION
It was determined that the Company possesses the ability to exercise significant influence over the operating and financial policies of Elo, an independent entity as of December 2021. Accordingly, the Company accounts for its investment in Elo under the equity method.
The Company owned approximately 26% of Elo’s voting shares outstanding as of December 31, 2024. In February 2025, Elo raised additional funding from its Series A-2 financing. The Company recognized a $2.3 million gain on dilution under the equity method during the three months ended March 31, 2025. The Company owned approximately 22% of Elo’s voting shares outstanding as of March 31, 2025. The Company’s proportionate share of Elo’s net loss for the three months ended March 31, 2025 and 2024 was $0.9 million and $1.0 million, respectively.
Note Receivable
The Company received common stock in Elo and a $10.0 million promissory note payable from Elo (the “Note Receivable”) which matures on the earlier of (i) December 1, 2028 or (ii) a Deemed Liquidation Event (as defined in the Elo’s Amended and Restated Certificate of Incorporation). As of March 31, 2025, the carrying value of the Note Receivable was $6.2 million including a $0.9 million decrease in the carrying value as a result of equity method investment losses. The remaining $3.8 million discount on the Note Receivable will be amortized to interest income over the life of the Note Receivable.
NOTE 10: Income Taxes
The Company estimates an annual effective tax rate of 0% for the year ending December 31, 2025 as the Company incurred losses for financial statement and tax purposes for the three months ended March 31, 2025 and is forecasting additional net losses for financial statement and tax purposes for the remainder of the year ending December 31, 2025. Therefore, no federal or state income taxes are expected, and none have been recorded at this time. Income taxes have been accounted for using the liability method in accordance with ASC 740, Income Taxes.
Due to the Company's history of losses since inception, there is not enough evidence at this time to support that the Company will generate future income of a sufficient amount and nature to utilize the benefits of its net deferred tax assets. Accordingly, the deferred tax assets have been reduced by a full valuation allowance, since the Company does not currently believe that realization of its deferred tax assets is more likely than not.
As of March 31, 2025, the Company hadno unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized.
NOTE 11: EARNINGS PER SHARE
The Company calculates basic net income (loss) per share by dividing net income (loss) for each respective period by the weighted-average number of common shares outstanding for each respective period. The Company computes diluted net income (loss) per share after giving consideration to the dilutive effect of unvested RSUs, stock options, unsettled ESPP contributions, and warrants that are outstanding during the period, except where such securities would be anti-dilutive.
The computations of basic and diluted net loss per share attributable to common stockholders are as follows:
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| (Loss) income from operations (in thousands) | $(20,565) | $8,588 |
| Net (loss) income (in thousands) | $(20,565) | $8,588 |
| Basic weighted-average common shares | 9,292,066 | 5,060,978 |
| Dilutive impact of share-based awards | — | 2,428 |
| Diluted weighted-average common shares (1) | 9,292,066 | 5,063,406 |
| Basic net (loss) income per share: | ||
| Basic (loss) income from operations | (2.21) | 1.70 |
| Basic net (loss) income per share | (2.21) | 1.70 |
| Diluted net (loss) income per share: | ||
| Diluted (loss) income from operations | (2.21) | 1.70 |
| Diluted net (loss) income per share | (2.21) | 1.70 |
(1) For the three months ended March 31, 2025 all outstanding total common stock equivalents were excluded from the diluted calculation as their inclusion would have been anti-dilutive.3,007,564 total common stock equivalents were excluded from the diluted weighted-average common shares calculation for thethree months ended March 31, 2024 as their inclusion would have been anti-dilutive.
NOTE 12: SEGMENT REPORTING
Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the chief operating decision maker or decision-making group (“CODM”) in making decisions on how to allocate resources and assess performance. The Company’s CODM, the Chief Executive Officer, views the Company’s operations asone operating segment, which includes the discovery and development of therapies utilizing our novel proprietary ARCUS platform. Our clinical and preclinical candidates were developed using the ARCUS platform to treat various forms of infectious and genetic disease.
The Company has not generated any revenue from product sales to date and expects to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through development and clinical trials. As such, the CODM uses cash forecast models in managing and allocating resources on a total company basis, such as pursuing clinical development or entering into potential strategic collaborations. The CODM assesses the overall level of resources available and how to best deploy these resources across functions and research and development projects that are in line with the Company’s long-term strategic goals.
Consistent with its management reporting, results of operations are reported on a Company-wide basis for purposes of segment reporting. The CODM uses Company-wide financial information, including net income (loss) and comprehensive income (loss), net cash used in operating activities for the period, and cash on hand for purposes of evaluating operating results and performance. As the Company operates inone operating segment, all measures of the segment assets are reported on the balance sheets as total assets. Please refer to the financial statements for further information related to these measures of segment performance.
The table below summarizes the significant research and development and general and administrative expense categories regularly provided to the CODM for thethree months ended March 31, 2025 and March 31, 2024:
| Three months ended March 31, | ||
|---|---|---|
| (in thousands) | 2025 | 2024 |
| Revenue | $29 | $17,584 |
| Operating expenses | ||
| Research and development | ||
| Direct research and development expenses by product candidate: | ||
| PBGENE-HBV external development costs | 1,601 | 3,056 |
| PBGENE-DMD external development costs | 2,438 | 175 |
| PBGENE-3243 external development costs | 2,165 | 1,212 |
| Platform development and early-stage research expenses: | ||
| Employee-related costs (including share-based compensation) | 5,300 | 5,380 |
| Laboratory supplies and services | 454 | 744 |
| CMOs and outsourced research and development | 56 | 228 |
| Facility-related costs, laboratory equipment, and maintenance | 728 | 810 |
| Depreciation and amortization | 340 | 891 |
| Licensing fees and other research and development costs | 506 | 847 |
| Total research and development expenses | $13,588 | $13,343 |
| General and administrative expense | ||
| Employee-related costs (including share-based compensation) | 5,460 | 5,009 |
| Consulting and professional services | 1,536 | 1,467 |
| Other operating expenses and all other costs | 1,557 | 1,952 |
| Total general and administrative expenses | $8,553 | $8,428 |
| Total operating expenses | $22,141 | $21,771 |
| Operating loss | (22,112) | (4,187) |
| Total other income | 1,547 | 12,775 |
| (Loss) income from operations | $(20,565) | $8,588 |
| Net (loss) income | $(20,565) | $8,588 |
NOTE 13: WARRANTS
The warrants issued in the March 2024 Public Offering are classified as a liability in accordance with ASC 815, since these warrants met the definition of a derivative instrument and did not qualify for equity classification. These warrant agreements include a fundamental transaction clause whereby, in the event that another person or entity becomes the beneficial owner of 50% of the outstanding shares of the Company’s common stock, and if other conditions are met, the Company may be required to purchase the warrants from the holders by paying cash in an amount equal to the Black-Scholes value of the remaining unexercised portion of the warrants on the date of such fundamental transaction. This liability is subject to remeasurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value is recognized in the Company’s condensed statements of operations.
The warrants were recorded at their fair value of $32.4 million at issuance based on the Black-Scholes option-pricing model. The following assumptions were used to estimate the fair value of the warrants at issuance:
| Estimated dividend yield | 0.00% |
|---|---|
| Weighted-average expected stock price volatility | 89.03% |
| Weighted-average risk-free interest rate | 4.17% |
| Expected term (in years) | 5.00 |
| Weighted-average fair value per option | $12.96 |
The fair value adjustment for the three months ended March 31, 2025 was $0.8 million using the Black-Scholes option-pricing model. As of March 31, 2025 all of the 2,500,000 warrants are outstanding. The Company estimated the fair value of the warrant liability using the following assumptions as of March 31, 2025:
| Estimated dividend yield | 0.00% |
|---|---|
| Weighted-average expected stock price volatility | 80.75% |
| Weighted-average risk-free interest rate | 3.92% |
| Expected term (in years) | 3.92 |
| Weighted-average fair value per option | $1.44 |
The following table summarizes the Company’s warrant liability (in thousands):
| Balance at December 31, 2024 | $2,796 |
|---|---|
| Issuance of warrants | — |
| Change in fair value of warrant liability | 804 |
| Balance at March 31, 2025 | $3,600 |
NOTE 14: SUBSEQUENT EVENTS
The Company has evaluated all subsequent events through the issuance date of these financial statements and no subsequent events occurred that required disclosure.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.